Ignite Creation Date:
2024-07-17 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470906
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-13
Brief Title:
Feasibility of an Oral Intervention for Sexual Health in Transgender Men
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Testosterone Effects on Sexual Health in Transgender Men Feasibility Study of an Oral Intervention
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEST-F
Brief Summary:
Transgender men TGM have a high incidence of sexually transmitted infected STIs including HIV HPV and bacterial N gonorrhea and C trachomatis In addition TGM who start testosterone therapy TT experience significant vaginal morbidity that causes vaginal dryness and pain due to the estrogen-inhibiting effects of TT on vaginal epithelium Vaginal dysbiosis is a known contributor of increased STI risk and vaginal symptoms In a future study the investigators are planning a randomized trial of a 6-month oral Lactobacillus probiotics intervention in TGM on TT at the Callen-Lorde Community Health Center CLCHC New York City to determine whether this intervention can improve vaginal health in TGM on TT In this study the investigators will conduct a pilot and feasibility study to precede the main trial The investigators will randomize 30 TGM on TT to receive either the intervention consisting of Lactobacillus acidophilus GLA-14 and Lactobacillus rhamnosus HN001 or placebo maltodextrin for 4 weeks evaluating the interventions impact on vaginal microbiota and clinical outcomes as well as its feasibility acceptability and adherence This study will take place at the CLCHC Brooklyn site aiming to gain pilot data address feasibility and acceptability and plan for the main trial accordingly
Detailed Description:
Transgender men TGM have a higher risk of sexually transmitted infections STIs associated with vaginal dysbiosis such as HIV HPV and bacterial N gonorrhea and C trachomatis compared to cisgender women CGW TGM on testosterone therapy TT also have increased vaginal symptoms Vaginal dysbiosis can be characterized as clinical-BV or molecular-BV ie based on vaginal microbiota profile Both are known contributors to increased vaginal symptoms and STI risk in CGW Low Lactobacillus LL levels determine molecular-BV and clinical-BV Studies show that TGM on TT show that they have a primarily LL vaginal microbiota The investigators are planning a future study to test the efficacy of an oral Lactobacillus probiotic to improve vaginal health
The goal for the future study is to test an intervention that the investigators hypothesize may be able to ameliorate some of the adverse health outcomes observed in TGM on TT Thus the investigators propose to use an intervention of a mixture of two components 1 the probiotic Lactobacillus acidophilus GLA14 and 2 the probiotic Lactobacillus rhamnosus HN001 Studies have shown that an oral combination of this intervention increases vaginal Lactobacillus levels and improves vaginal health in CGW The future study will test whether this intervention is effective in TGM on TT This specific study is a pilot study to be conducted prior to the future study detailed above Here the investigators will randomize 30 TGM on TT to receive the intervention or placebo for 4 weeks The intervention in the pilot study will be the same as the intervention of the main trial and will consist of the probiotics 1 Lactobacillus acidophilus GLA-14 and 2 Lactobacillus rhamnosus HN001 The placebo will be maltodextrin the same as the proposed larger study The investigators will assess the effect of the intervention on clinical-BV molecular-BV based on vaginal microbiota and other clinical outcomes Further the investigators will determine the feasibility acceptability and adherence of the intervention The investigators will conduct the pilot study at the CLCHC Brooklyn site This pilot study will allow us to generate preliminary data determine the feasibility and acceptability and plan appropriately for the future study
The goal for the future study is to test an intervention that the investigators hypothesize may be able to ameliorate some of the adverse health outcomes observed in TGM on TT Thus the investigators propose to use an intervention of a mixture of two components 1 the probiotic Lactobacillus acidophilus GLA14 and 2 the probiotic Lactobacillus rhamnosus HN001 Studies have shown that an oral combination of this intervention increases vaginal Lactobacillus levels and improves vaginal health in CGW The future study will test whether this intervention is effective in TGM on TT This specific study is a pilot study to be conducted prior to the future study detailed above Here the investigators will randomize 30 TGM on TT to receive the intervention or placebo for 4 weeks The intervention in the pilot study will be the same as the intervention of the main trial and will consist of the probiotics 1 Lactobacillus acidophilus GLA-14 and 2 Lactobacillus rhamnosus HN001 The placebo will be maltodextrin the same as the proposed larger study The investigators will assess the effect of the intervention on clinical-BV molecular-BV based on vaginal microbiota and other clinical outcomes Further the investigators will determine the feasibility acceptability and adherence of the intervention The investigators will conduct the pilot study at the CLCHC Brooklyn site This pilot study will allow us to generate preliminary data determine the feasibility and acceptability and plan appropriately for the future study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None